pharmacokinetic evaluation of brisdelle™ (formerly known as mesafem) following single & repeat oral administration in healthy postmenopausal women

Conditions: Postmenopausal Symptoms

Summary: the purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of brisdelle (paroxetine mesylate) capsules 7.5 mg when given as a single dose and multiple doses.

this study is for research only and is not designed to treat a medical condition.

Eligibility criteria:
inclusion criteria: subjects who are healthy postmenopausal, non-smoking women of any race and ≥40 years of age at screening. exclusion criteria: subjects who have a recent history or presence of glaucoma, migraines, cardiovascular, hepato-biliary, renal, gastrointestinal, neurologic, psychiatric, dermatologic, pulmonary, cerebrovascular, endocrine, hematologic, thromboembolic, immunologic disease or any other disorder which requires physician care; subjects who have existing medical conditions which might interfere with absorption, distribution, metabolism, or excretion of study medication; history of self-injurious behavior; history of clinical diagnosis of depression; or treatment for depression; history of clinical diagnosis of border-line personality disorder; presence of any of the following psychiatric disorders within the timeframes specified: major depressive disorder-lifetime; dysthymia-past 2 years; bipolar disorder-lifetime; panic disorder-lifetime; agoraphobia-past month; social phobia-past month; obsessive compulsive disorder-past month; generalized anxiety-lifetime; psychotic disorders-lifetime; anorexia nervosa-past 10 years; bulimia-past 10 years; suicidality/suicide ideation-lifetime; post traumatic stress disorder-lifetime. subjects with a history of seizures; sitting blood pressure (bp) \ 150/90 mmhg; sitting heart rate (hr) \ 90 beats/min; clinical laboratory test results outside of the normal range for the laboratory conducting the test; positive urine pregnancy test at screening or day 0; subjects who have a history of sensitivity to active and/or inactive ingredients in brisdelle (paroxetine mesylate) capsules 7.5 mg; subjects who have a history of significant allergies; subjects who have a present or past history of narcotic addiction, drug abuse, or alcoholism; subjects who have smoked or used tobacco during the last 6 months; subjects who have donated one or more pints of blood within 30 days prior to treatment administration; subjects who have symptoms of any significant acute illnesses at the screening visit; subjects who used any investigational drug within 30 days prior to treatment administration; subjects who took any substances known to be cytochrome p450 2d6 (cyp2d6) inhibitors within 14 days of study start and throughout the entire study; subjects who used any prescription medications within 14 days of the screening visit; subjects who used st john's wort within 14 days of the screening visit; subjects who used any over the counter preparations including herbal or nutritional supplements and multivitamins within 10 days prior to receiving the first study treatment; subjects who have consumed foods or beverages containing caffeine/xanthine or alcohol; subjects who have a positive screen for hepatitis b surface antigen (hbsag) or hepatitis c antibody; subjects who have a positive screen for the human immunodeficiency virus (hiv) antibody; subjects who have a positive urine drug screen; subjects who have any clinically significant illness within 90 days prior to receiving the first dose of study medication.

Keywords: menopause hot flashes vasomotor symptoms climacteric symptoms perimenopause mesafem brisdelle low-dose mesylate salt of paroxetine (ldmp)